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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG 3/4-SIZE LID W/RETENTION PLATE SILVER STERILE TECHNOLOGY

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AESCULAP AG 3/4-SIZE LID W/RETENTION PLATE SILVER STERILE TECHNOLOGY Back to Search Results
Model Number JK789
Device Problem Device Contaminated During Manufacture or Shipping (2969)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/22/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Manufacturing site evaluation: evaluation on-going.
 
Event Description
(b)(6). Whitish deposit on the inside of the lid.
 
Manufacturer Narrative
Investigation: several containers are concerned. This surface change is most likely due to an alkaline washer solution above the permitted level. Conclusion and root cause: based on the information available as well as a result of our investigation the root cause of the failure is most probbaly related to an insufficient maintenance of the device. Rational: to avoid this change treat products with anodized surfaces in a neutral ph/mildly alkaline environment. Care instructions can be found in the ifu. No capa is necessary.
 
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Brand Name3/4-SIZE LID W/RETENTION PLATE SILVER
Type of DeviceSTERILE TECHNOLOGY
Manufacturer (Section D)
AESCULAP AG
po box 40
tuttlingen, 78501
GM 78501
Manufacturer (Section G)
AESCULAP AG
po box 40
tuttlingen, 78501
GM 78501
Manufacturer Contact
nicole broyles
615 lambert pointe drive
hazelwood, MO 63042
3145515988
MDR Report Key7271721
MDR Text Key100126743
Report Number9610612-2018-00045
Device Sequence Number1
Product Code FRG
Combination Product (y/n)N
Reporter Country CodeNC
PMA/PMN Number
K053389
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/14/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberJK789
Device Catalogue NumberJK789
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date01/24/2018
Event Location No Information
Date Manufacturer Received01/22/2018
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/14/2018 Patient Sequence Number: 1
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